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At present, the Food and Drug Administration is considering downgrading the Electroshock device used in Electroconvulsive Treatment (ECT) from Class III to Class II. Below is an excerpt from an article (“Shock Devices Safe as Eyeglasses?”) by Lauren Tenney, with more details:

"The electroshock device, the actual machine that is used to deliver shock treatment (electroconvulsive treatment/ECT), is currently a Class III device as categorized by the Food Drug and Cosmetic Act of 1976. Under FDA standards, a medical device is placed into Class III when its risks and benefits have not been assessed to a degree that allows it to be placed into Class I or Class II, and thus there is potential that its risks outweigh its benefits."

The electroshock device, the actual machine that is used to deliver shock treatment (electroconvulsive treatment/ECT), is currently a Class III device as categorized by the Food Drug and Cosmetic Act of 1976. The FD&C Act requires all medical devices to be placed into one of three categories: Class I (general controls); Class II (special controls); and Class III (premarket approval). (FDA, 2015, p. 81224i).

Under FDA standards, a medical device is placed into Class III when its risks and benefits have not been assessed to a degree that allows it to be placed into Class I or Class II, and thus there is potential that its risks outweigh its benefits. A Class III device is one that either was in existence prior to 1976 and is therefore referred to as a

pre-amendments device, or if it has come onto the market since 1976 and its manufacturer claims it is similar to a pre-1976 device, it is referred to as a post-amendments device.

To help decipher this, I turn to the must-read groundbreaking work of Linda Andre, “Doctors of Deception: What They Don’t Want You to Know about Shock Treatment”.ii Andre tells the sordid history of the shock device and resulting procedure, crafting a meticulously-detailed account of the horrors of electroshock. Concerning the FDA’s classification system, Andre wrote:

“Class III is the high-risk classification for those devices for which general controls or performance standards are insufficient. The FDA defines Class III devices as those for which ‘benefits have not been shown to outweigh risks’ and which present ‘a potential unreasonable risk of injury or illness’ when used as directed by the manufacturer for their intended purpose. The degree of oversight necessary to ensure maximum safety was known as ‘premarket approval’. The name reflected the fact that even though a device might have been on the market for many years, its status was similar to that of a new device. It hadn’t proven itself to the FDA. Its manufacturers would, when called on by the agency, have to submit a premarket approval application (PMA) in which it would have to prove its safety and efficacy” (p. 139).

As discussed by Andre (2009) and the FDA (2015), over the decades there have been multiple attempts to down-classify the shock device to a Class II device, which would classify the shock device as safe and effective. This would put the shock device in the same category as eyeglasses or wheelchairs—other medical devices that are Class II, requiring “special controls.”